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Identification of medicinal products (IDMP)An opportunity to unlock the value of product data

1 Identification of medicinal products (IDMP) An op p ortunity to unl ock th e val ue of p roduct data

ontentsE xecutive sum m ary 2

I ntroduction 2

Th e j ourney tow ard im p roved p atient saf ety 3

U sing com p l iance as a catal yst to ach ieve b usiness val ue 3

D if f erent ap p roach es, a com m on g oal 6

U nl ock ing b etter p roduct l if e cycl e m anag em ent, p atient f ocus and op erational innovation 9

B uil ding stak eh ol der trust 1 0

F ocus on p h arm a: b ut w h at ab out anim al h eal th ? 1 0

R eal iz ing th e f ul l p otential of I D M P com p l iance 1 1

2Identification of medicinal products (IDMP) An op p ortunity to unl ock th e val ue of p roduct data

ecuti e summarAs of Ap ril 2 0 1 7 , w h en th is p ap er w as w ritten, th e initial im p l em entation date of 1 J ul y 2 0 1 6 f or

I Istandards h ad p assed. H aving b een sup erseded b y an iterative ap p roach , th ere is stil l uncertainty surrounding im p l em entation g uidance f rom th e I nternational O rg aniz ation f or S tandardiz ation ( I S O ) and th e E urop ean M edicines Ag ency ( E M A) . M ark eting auth oriz ation h ol ders are now considering h ow and w h en to invest in I D M P com p l iance. At E Y , our exp erience is th at com p anies are adop ting dif f erent strateg ies to deal w ith th e uncertainty, w ith m ost now restructuring p rog ram s to b al ance reg ul atory uncertainty w ith th e need to m aintain m om entum in som e critical areas. I n th e end, h ow ever, al l w il l h ave to com p l y w ith th e sam e standards, creating p otential f or industry- w ide col l ab oration on certain non- com p etitive top ics.

M uch of th e uncertainty is rel ated to understanding th e reg ul atory p ersp ective of ch ang ing scop e and tim el ines f or I D M P I terations 1 and 2 . N ow , in earl y 2 0 1 7 , th e tw o k ey q uestions b iop h arm aceutical com p anies are trying to answ er are:

1 . W h y act now ?

2 . W h at sh oul d w e p rioritiz e?

I n t r o d u c t i o nAccording to W orl d B ank data, th e averag e l if e exp ectancy in O rg aniz ation f or E conom ic C o- op eration and D evel op m ent ( O E C D ) countries h as increased f rom 6 5 years in 1 9 6 0 to 7 8 years in 2 0 1 4 1 . O ver th e p ast 2 0 years, th e b iop h arm aceutical industry h as devel op ed l if e- al tering p roducts th at h ave extended l ong evity and

il l nesses can now b e m anag ed ef f ectivel y or even cured.

I nevitab l y, w ith th ese l if e- enh ancing im p rovem ents com e p roduct usag e and saf ety risk s. Today, inf orm ation rel evant to th ose risk s is b uried in m il l ions of p ag es of docum ents sp anning disp arate system s and sp readsh eets, in m ul tip l e dif f erent f orm ats. I m p roving access to and visib il ity of such data w il l h el p reg ul ators, h eal th care p roviders and l if e sciences com p anies im p rove th e saf e use of th eir m edicines.

impro in isi ilit of and access to information on p armaceutical products is a step to ard impro in patient safet

► M edical errors af f ect 23% of E urop ean U nion ( E U ) citiz ens.

► I n th e E U , of p atients are p rescrib ed th e w rong m edicine.

► Th e typ ical U S p atient tak es medications routinel y.

► Medication errors are th e b ig g est p reventab l e cause of inj ury f or U S p atients.

1 O E C D ( 2 0 1 7 ) , L if e exp ectancy at b irth ( indicator) . doi: 1 0 . 1 7 8 7 / 2 7 e0 f c9 d-en ( accessed on 1 3 M arch 2 0 1 7 ) .


T h e j o u r n e y t o w a r d i m p r o v e d p a t i e n t s a f e t yI n 2 0 0 1 , th e E M A introduced a new saf ety m onitoring datab ase, E udraV ig il ance. I ts intent w as to h el p track susp ected drug - adverse events f or b oth devel op m ent- stag e and m ark eted p h arm aceutical p roducts across th e E urop ean E conom ic Area ( E E A) . F ol l ow ing th is, in 2 0 0 5 , th e E M A l aunch ed th e E udraV ig il ance M edicinal P roduct

w h ol l y dig ital p l atf orm . Th is dig itiz ation catal yz ed th e introduction of standard data f orm ats and data exch ang e p rocesses f or p roduct saf ety inf orm ation. S ince th e creation of th e E udraV ig il ance w eb interf ace, E V W E B , E M A w ork ed w ith industry exp erts and th e I S O to create a m ore com p reh ensive data m odel and associated standards req uired to identif y m edical p roducts th at w ere p ub l ish ed in 2 0 1 2 . I S O I D M P h as b een in continual devel op m ent ever since.

R eg ul atory auth orities view th e standards as not onl y a m eth odol og y f or describ ing a m edicinal p roduct, b ut al so a m eans to f acil itate inf orm ation exch ang e and anal ysis th roug h h arm oniz ed data el em ents, f orm ats and term inol og ies across th e E U .

Af ter th e initial rel ease of th e I S O international standards in 2 0 1 2 , m any l if e sciences com p anies rap idl y m oved into action, w ith m ost conducting g ap anal yses to assess th e f orth com ing reg ul ation and

f or com p l iance. H ow ever, th e standards are stil l evol ving , and f urth er revisions are exp ected in addition to th e p ub l ication of tech nical

th e im p l em entation g uidel ines to sup p ort th e I S O international standards.

U s i n g c o m p l i a n c e a s a c a t a l y s t t o a c h i e v e b u s i n e s s v a l u eID M P is p rim aril y a com p l iance ch al l eng e th at ap p eared to b e w el l

ab out th e scop e and tim el ine f or th is reg ul ation due to a series of

stated im p l em entation tim el ine is l ink ed to th e p ub l ication of its g uidance; yet th e industry is stil l aw aiting th e g uidance, w h ich is now due som etim e in m id- 2 0 1 8 .

eason for concern ► Th e introduction of a p h ased im p l em entation sch edul e

► R ep eated tim el ine sh if ts

► C h ang ing scop e w ith in each I teration

► D el ays in th e tech nical sol utions

►

W h il e f ocusing on th e standards and h ow to im p l em ent th em , m any p l ayers h ave l ost sig h t of th e orig inal intent b eh ind I D M P — to im p rove p atient saf ety. Th is w as ag ain set out in th e M arch - Ap ril

Irol e th at I D M P standards are exp ected to p l ay in reducing th e g l ob al incidence of inj ury and death due to p h arm aceutical m isuse. 2

2 ISOfocus, I ssue # 1 1 5 , M arch - Ap ril 2 0 1 6 , p p 6 - 1 5

4

F or exam p l e, th e num b er of p roduct recal l s b y th e U . S . F ood and D rug Adm inistration ( F D A) al one increased b y m ore th an 1 , 7 0 0 % b etw een 2 0 0 4 and 2 0 1 5 ( see F ig ure 1 ) . Th is rep resents eith er a saf ety or q ual ity risk f or consum ers and a sub stantial cost f or th e sector. O nce com p anies’ p roduct data is in I D M P - com p l iant f orm at,

w il l tracing it th roug h th e sup p l y ch ain.

Th eref ore, rath er th an ask ing , o do e ac ie e IDMP compliance com p anies sh oul d b e ask ing :

F ig ure 1

um er of D dru recallsI ncreasing num b er of drug recal l s f rom 2 0 0 4 th roug h 2 0 1 5 underp in th e need f or h ig h transp arency.

S ource: op enF D A drug recal l enf orcem ent

um er of cases

1 1 62 5 3

1 1 6 1 2 62 0 3 1 6 4

2 4 6

4 4 4 4 9 9

1 , 2 2 5

2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 4 2 0 1 5

1 , 5 4 0

2 , 0 5 2

+1,770%

o do e use t is information to impro e patient safet uild trust and dri e operational efficiencies across our usiness


As th e I D M P im p l em entation tim el ine evol ves, m any com p anies h ave strug g l ed to retain sp onsorsh ip and investm ent f or th eir I D M P initiatives. S om e of th e m ain reasons q uoted b y m any of th e cl ients w e h ave interview ed are l isted b el ow .

o confidence in t e re ised implementation sc edule m any executives are b ecom ing increasing l y f rustrated w ith th e ong oing del ays to I D M P im p l em entation g uidance. Th e E M A h as com m itted to a “ 1 2 + 6 m onth ” tim el ine f or im p l em entation and enf orcem ent. As th is b eg ins w ith th e p ub l ication of th e im p l em entation g uidance, I teration 1 m ay not h ap p en until 2 0 1 9 or l ater in E urop e. At th is p oint, it isn’ t inconceivab l e f or oth er reg ul atory auth orities to im p l em ent I D M P b ef ore th e E M A. M oreover, m any b el ieve th e th reatened sanctions f or non- com p l iance are unl ik el y to b e im p osed, at l east in th e earl y years. As a resul t, m any com p anies are considering dep rioritiz ing som e or al l of th eir I D M P investm ents.

IDMP Iteration not seen as si nificantl different from current product data re uirements th e eX tended E udraV ig il ance M edicinal P roduct D ictionary ( X E V M P D ) h as al ready b een a com p l iance

data attrib utes b etw een th e tw o reg isters, critics h ave q uestioned w h eth er I teration 1 w il l add anyth ing m eaning f ul to p atient saf ety.

n o erload of re ulation w ith th e revised I D M P im p l em entation sch edul e soon com ing into ef f ect, th e industry is deal ing w ith a p l eth ora of oth er m edicinal p roduct and device standardiz ation initiatives across reg ions, som e of w h ich interf ace w ith I D M P .

of E 2 B ( R 3 ) f or saf ety rep orting and th e E U C l inical Trial s P ortal ( see F ig ure 2 ) . F or sp onsors, it is not al w ays cl ear if and h ow th ese initiatives are l ink ed and, th eref ore, w h ere to p rioritiz e g iven l im ited resources.

n o erload for t e re ulator th e reg ul ators th em sel ves f ace overl oad as th ey seek to im p l em ent com p l ex initiatives w ith th eir ow n resource constraints. Th is exp l ains not onl y th e m ul tip l e del ays to I D M P im p l em entation, b ut al so del ays to enab l ing system s such as th e E M A’ s R ef erential s M anag em ent S ystem ( R M S ) ( f or m anag ing p roduct attrib ute data) and O rg aniz ation M anag em ent S ystem ( O M S ) , as w el l as th e U S F D A tim el ines f or its G l ob al S ub stance R eg istration S ystem ( G - S R S ) .

re it uncertaint w h en th e U K invok es Articl e 5 0 to l eave th e E U , exp ected in 2 0 1 7 , it is h ig h l y l ik el y th at th e E M A w il l sh if t f rom its current U K - b ased h eadq uarters to som ew h ere el se in E urop e. Th oug h th is is stil l an outside consideration, it is h ig h l y l ik el y to

reg ul atory ch ang e.

At E Y , w e b el ieve th e del ays in th e I D M P im p l em entation sch edul e of f er com p anies an op p ortunity to b etter integ rate I D M P com p l iance ef f orts w ith oth er ong oing or p l anned initiatives th at are f ounded up on rob ust, com p l ete and com p l iant p roduct data. Th ese m ay incl ude

serial iz ation, “ g ood m anuf acturing p ractice” q ual ity initiatives and m ore. S uch integ ration w il l h el p accel erate com p l iance and del iver g reater val ue to al l stak eh ol ders.

F ig ure 2

E V M P D2 0 0 1 2 0 1 2 2 0 1 7 2 0 1 8 2 0 1 9 2 0 2 0

X E V M P D I D M P

I D M P S P O R data m anag em ent services

E l ectronic sub m ission ( eAF and C E S S P )

V eterinary m edicinal p roduct sub m ission

S af ety rep orting ( E 2 B ( R 3 ) )

C l inical trial s M anag em ent in E U ( E U C T reg ul ation)

F D A structured p roduct l ab el l ing

S P O R : O M S and R M SI teration 1 : P M S and S M S

F D A drug sup p l y ch ain sec act

M ark eting auth oriz ations

Adop tion of S P L ( R 5 ) to I D M P standard ( H L - 7 )

N ote: Tim el ines are b ased on current inf orm ation and are sub j ect to ch ang e.

V ariations

E V V et3 sub m ission ( central iz ed sub m ission)

I D M P ( P H P I D and M P I D ) and I C H E 2 B ( R 3 ) drug

saf ety datab ase up g rade to sup p ort new data el em entsE U p ortal avail ab il ity; I M P I D M P interf ace and C T rep orting

and anti- tam p er devices

P rioritiz ed E U initiative


D i f f e r e n t a p p r o a c h e s , a c o m m o n g o a lAcross th e industry, com p anies are p l anning f or I D M P im p l em entation in a variety of w ays. S om e are tak ing a m ore cautious, w ait- and- see ap p roach — typ ical l y, m idsiz e com p anies w ith sm al l er p ortf ol ios — w h il e oth ers h ave anticip ated I D M P req uirem ents and tim el ines, and m oved to integ rate com p l iance ef f orts w ith oth er f unctions and p rocesses in th e org aniz ation. Al l f ace th e ch al l eng e

II

exp erience of sup p orting I D M P p rog ram s, w e h ave ob served th ree ap p roach es to addressing th e dem ands of th ese reg ul ations:

e anal sts

► V iew I D M P as an isol ated com p l iance ch al l eng e

► R el uctant to com m it resources to I D M P b ef ore g uidel ines are

► P roj ect l eadersh ip is at reg ul atory or I T team l evel

Th e anal ysts are th e com p anies th at view I D M P as p rim aril y a com p l iance ch al l eng e. Al th oug h th ey k eep a cl ose eye on em erg ing im p l em entation g uidance, th ey w ant to see g reater certainty on b oth th e standards and th e im p l em entation g uidance b ef ore com m itting th e necessary b udg et and resources to address th e ch al l eng e.

Typ ical l y, th ese are m idsiz e com p anies w ith sm al l er p ortf ol ios and l ow er data b urdens f rom l eg acy or acq uired p roducts th an th eir l arg er p eers. An I D M P team m ay h ave

b usiness readiness. P roj ect l eadersh ip is typ ical l y f rom reg ul atory or R & D I T, w ith a rel ativel y l ow l evel of active b usiness inp ut. I n m any cases, executive sp onsors do not view I D M P as a p riority f or investm ent f unding , due p rim aril y to th e ong oing sh if ts in scop e and tim el ines.

e pra matists

► P roactivel y im p l em ent I D M P w ith dedicated team s, tim el ines and p rocesses

► F ocus on accessing and rem ediating data f rom l eg acy system s

► R arel y tak e a h ol istic ap p roach b eyond data and system s to incl ude exp ertise and org aniz ational ch ang e

Th ese com p anies are activel y m oving ah ead w ith th eir I D M P im p l em entation p rog ram s. D edicated p roj ect team s h ave b een estab l ish ed, and th ere is l ik el y active rep resentation in th e I S O and sub stance, p roduct, org aniz ation and ref erential ( S P O R ) task f orces. W ork to date h as f ocused on asp ects of I D M P im p l em entation th at are

f or X E V M P D p urp oses.

Arch itectural decisions h ave b een m ade, w h ich typ ical l y invol ve a m ul tiyear road m ap tow ard a m ature I D M P data l andscap e and resol ution of m aster data m anag em ent ( M D M ) g ap s. S el ection of tech nical p l atf orm s is under w ay, and th ere are cl ear val idation ch eck p oints l ink ed to anticip ated m il estones f or rel ease of im p l em entation g uidance b y th e I S O and th e E M A. C urrent w ork f ocuses on addressing th e ch al l eng es of accessing data f rom l eg acy system s or docum ents.

Th ese com p anies h ave estab l ish ed I D M P team s w ith rep resentation f rom I T, reg ul atory and, in som e cases, b roader g roup s, incl uding m anuf acturing and sup p l y ch ain. H ow ever, in m any cases, th e f ocus h as b een on data and system s. F ew h ave adop ted a h ol istic ap p roach , encom p assing th e associated p rocess and org aniz ational ch ang es req uired f or a sustainab l e, I D M P - com p l iant op erating m odel .


e isionaries

► I nvest earl y in I D M P com p l iance and rel ated enterp rise resource p l anning ( E R P ) or M D M p rog ram s

► Ap p roach I D M P h ol istical l y as a m eans f or g reater org aniz ational

► I nvol ve m ature data stew ardsh ip across th e org aniz ation, som etim es w ith h ig h - l evel sp onsorsh ip

A sm al l num b er of b iop h arm aceutical com p anies h ave b een track ing and investing I

M any of th ese com p anies recog niz ed earl y on th e op p ortunity th at I D M P coul d of f er th eir b usinesses and h ave invested according l y. Typ ical l y, th ey h ave b een ab l e to al ig n and l everag e p aral l el enterp rise E R P or M D M p rog ram s, th ereb y reducing th e increm ental ef f ort and cost of m eeting I D M P standards in isol ation, w h il e accel erating

p roduct recal l s.

F or instance, al ig ning th ese initiatives al l ow s f or dup l ication of ef f ort to b e m inim iz ed or el im inated, sup p orting b etter data integ rity and b etter util iz ation of resources. Th is is sup p orted b y org aniz ational ch ang e m anag em ent across th e enterp rise rath er th an w ith in m ul tip l e, isol ated p ock ets, th ereb y im p roving accep tance.

data stew ardsh ip netw ork across th e org aniz ation. H ow ever, th ey are f acing consistent ch ang e m anag em ent ch al l eng es reg arding h ow b est to address th e p rocess or b eh avioral ch ang es needed f or ong oing reg ul atory com p l iance.

Th is ap p roach req uires th e h ig h est l evel of sp onsorsh ip and sustained l eadersh ip across th e b usiness, not j ust in reg ul atory or I T. R el ativel y f ew com p anies in th e industry are in th is p osition.

Th e strateg y to determ ine w h ich ap p roach to adop t dep ends on a num b er of f actors, incl uding org aniz ation siz e and l eg acy, p ortf ol io siz e and l evel of inf orm ation m aturity. A f urth er f actor is th e ab il ity to invest internal resources in b uil ding a p roduct inf orm ation l andscap e th at drives tow ard val ue, rath er th an f ocusing on reg ul atory com p l iance.


EY I D M P m a t u r i t y a s s e s s m e n t

e components of t e or ani ation

e el e el e el e el e el

Pro ram o ernance

N o g l ob al b usiness sp onsor

I D M P

N o f orm al p rog ram estab l ish ed

S ing l e f unctional sp onsor at m iddl e m anag em ent

E xecutive sp onsorsh ip m issing

C ross- f unctional m iddl e m anag em ent sp onsorsh ip

E xecutive sp onsorsh ip m issing

O utl ine b usiness case created

C ross- f unctional sp onsorsh ip , w ith steering com m ittee sup p ort at executive l evel

P rog ram risk m anag em ent in p l ace

C l ear understanding of b usiness case

C ross- f unctional sp onsorsh ip , w ith strong executive sup p ort and strong org aniz ational vision

Active p rog ram risk m anag em ent and p roj ect com m unication

b usiness case

Pro ram inte ration

N o f orm al p rog ram estab l ish ed

I D M P p roj ect started as a stand- al one p rog ram b y R A

I D M P p roj ect started as a j oint p roj ect am ong I T, R A and R & D

I D M P p rog ram started as p art of a b roader M D M or R I M initiative w ith cross- f unctional ow nersh ip

I D M P integ rated w ith M D M or R I M , p l us oth er core rel ated initiatives

cross- f unctional ow nersh ip

Portfolio assessment

N o f orm al assessm ent com p l eted

P roducts w ith in E E A h ave b een assessed th roug h

( P S M F ) p roduct l ist and X E V M P D sub m ission

C l ear understanding of g ap s

C om p l eted E E A p ortf ol io assessm ent: X E V M P D sub m ission, stock - k eep ing units ( S K U s) b y country, l if e cycl e stag e, p roduct acq uisition h istory, and devel op m ent h istory

C om p l eted cross- reg ional p ortf ol io assessm ent ( E E A

typ es, S K U s b y reg ion, l if e cycl e stag e, p roduct acq uisition h istory, and devel op m ent h istory

C om p l eted g l ob al p ortf ol io

typ es, S K U s b y reg ion, l if e cycl e stag e, p roduct acq uisition h istory, and devel op m ent h istory

M aster g l ob al p roduct l ist avail ab l e

Data source identification

N o data source anal ysis or I D M P m ap p ing com p l eted

D ata m ap p ing com p l eted f or p il ot p roducts onl y ag ainst initial I D M P or X E V M P D data attrib utes in scop e f or I teration 1

P il ot p roducts data m ap p ing com p l eted ag ainst l atest I D M P or X E V M P D data m odel

f orm ats across l if e cycl e and

C om p l eted deep dive into k ey p roduct g roup s b ased on p ortf ol io assessm ent

across l if e cycl e, and strateg ies f or extraction and conversion

cycl e, and strateg ies f or extraction, conversion and data up l oad

vocab ul ary m aintenance ap p roach

q ual ity dash b oard

I s stems transformation

N o system s m ap p ing com p l eted

S ystem s m ap p ing com p l eted as p art of th e P S M F

S ystem s m ap p ing com p l eted ag ainst data sources f or al l k now n attrib utes in I D M P m odel

Iop p ortunities f or integ ration and al ig ned w ith enterp rise I T road m ap

inf orm ation g overnance m odel , al ig ning I D M P and b roader M D M

arch itecture, incl uding integ ration w ith external system s ( U C U M , G - S R S )

g overnance m odel ; system s arch itecture, incl uding integ ration w ith external system s ( U C U M , G - S R S )

IM D M op erating m odel and g overnance org aniz ation

Process and people transformation

N o p rocess or p eop l e im p act assessm ent com p l eted

H ig h - l evel im p act assessm ent com p l eted

Ip eop l e and p rocess im p l ications

S tak eh ol der m ap devel op ed

C om p l eted f ul l p rocess and p eop l e im p act assessm ent across th e l if e cycl e

f or p rocess ch ang es and integ ration w ith oth er initiatives

Iq ual ity m anag em ent system ( Q M S ) and w h eth er new p ol icies are needed

transf orm ation to sup p ort I D M P , M D M and R I M transf orm ation

Q M S up dates p l anned ag ainst k now n sch edul e f or I D M P iterations

R esp onsib l e, accountab l e, consul ted and inf orm ed ( R AC I ) anal ysis and training needs assessm ent com p l eted

p rocess and Q M S m odel integ rating I D M P and M D M , R I M and oth er reg ul atory initiatives

Al l Q M S docum ents up dated w ith

I

Training com p l eted on al l p rocess and Q M S up dates

C ontinual im p rovem ent and corrective


U n l o c k i n g b e t t e r p r o d u c t l i f e c y c l e m a n a g e m e n t , p a t i e n t f o c u s a n d o p e r a t i o n a l i n n o v a t i o nTo understand th e im p act of I D M P on th e b usiness and th e op p ortunities p resented b y com p l iance, com p anies need to step b ack f rom th e assum p tion th at th is is p rim aril y an I T p rog ram . I Iand across th e industry, w h ich w il l f ar outw eig h th e initial cost of com p l iance, p rovided th ere is an ap p rop riatel y integ rated ap p roach .

Th e k ey strateg ic val ue of im p l em enting I D M P ( and rel ated reg ul ations) is to sup p ort p atient saf ety and th e transp arency of m edicinal p roduct data. I t al so enab l es im p roved eval uation of risk

f ocused traceab il ity of p roducts and th eir com p onents. C ol l ectivel y, th ese f acil itate a m ore p atient- centric ap p roach to p roduct l if e cycl e m anag em ent, in addition to enh anced risk and vendor m anag em ent. F urth erm ore, com m on data m odel s th at p rom ote enterp rise- w ide data m astering , coup l ed w ith strong g overnance

and q ual ity m easures, w il l increase data integ rity b y several orders of m ag nitude. Th ese m odel s rep resent an op p ortunity to create

m anag em ent and enab l ing b etter control of inf orm ation th at can l ead to th e el im ination of adm inistrative activities, such as data discrep ancy reconcil iation. Th at val ue w il l increase f urth er b eyond 2 0 2 0 as I D M P ap p roach es f ul l im p l em entation.

I D M P w il l al so p l ay a critical unif ying rol e as b roader f orces — incl uding th e dig itiz ation of h eal th care, p recision m edicine, consum er em p ow erm ent, novel anal ytics tool s and p rocess autom ation — enab l e new f orm s of innovation across h eal th care p roducts and th eir del ivery. I D M P w il l p rovide a com m on data “ core” th at w il l b ecom e th e f ram ew ork f rom w h ich to ach ieve new , m ore am b itious g oal s in m edicinal p roduct innovation and l if e cycl e m anag em ent in an increasing l y dig ital w orl d.

I D M P I teration 1 w il l im p act m ark eted p roducts onl y, th oug h th e scop e w il l q uick l y exp and to investig ational p roducts ( iteration 2 )

D disco er

► L ittl e or no im p act anticip ated

► K ey inf orm ation f rom I N D or I D M P , incl uding sub stance, excip ient, intended use, p resentation and k now n saf ety inf orm ation

► U p dates f rom D S U R s P S U R s

► F orm ul ation data

► S tab il ity of cl inical b atch es

► E f f ective f rom iteration 2 ( E M A)

► F orm ul ation

► L ab el ing

► R eg istration status

► I nteg rity of sup p l y

control s

► R isk of sup p l y sh ortang e

► S erial iz ation

► M anuf acturer nam es — internal and th ird p arty

► I nitial S m P C

► V ariations — l ab el ch ang es, f orm ul ation ch ang es, p resentation ch ang es

► R enew al s

► W ith draw al s

► I ntended cl inical use

► Ap p roved indications

► C ontradictions and p recautions

► I ndividual case rep orting

► I nternational b irth date

► R eg istration status p er m ark et

► P S U R status

De elopment uppl c ain Manufacturin and distri ution ommercial Post mar et

A typ ical “ b ig p h arm a” com p any w il l need to maintain more t an million data fields th roug h out th e l if e cycl e, necessitating integ rated, rel iab l e p rocess b eyond initial sub m ission.

1 0Identification of medicinal products (IDMP) An op p ortunity to unl ock th e val ue of p roduct data

B u i l d i n g s t a k e h o l d e r t r u s tTh e current reg ul atory del ays create a w indow f or l if e sciences com p anies to undertak e th ese actions in a considered f ash ion, sup p orted b y ch ang e m anag em ent activities th at can drive val ue th roug h out th e org aniz ation, not j ust w ith in I T and reg ul atory op erations.

O ne of th e g reatest val ues w il l b e im p roved trust. I D M P can f orm th e b asis f or estab l ish ing g reater trust b etw een th e b iop h arm aceutical industry and its stak eh ol ders, incl uding p atients, p ayors, reg ul ators and p h ysicians. Typ ical l y, th e industry h as scored l ow on trust as a resul t of num erous f actors, incl uding p roduct saf ety issues, q uestionab l e p rom otional activities, op aq ue p ricing m eth odol og ies

Ish arp f ocus p atient and p ub l ic h eal th val ue, af f ording an op p ortunity to com m unicate p roduct q ual ity, saf ety and transp arency. B uil ding

ach ieved th roug h th ese ef f orts. To stop now is not an op tion.

F o c u s o n p h a r m a : b u t w h a t a b o u t a n i m a l h e a l t h ?U ntil recentl y, veterinary p roducts w ere not in th e p l anned scop e of initial E M A iterations. B ut th is h as ch ang ed. I t is now l ik el y th at I D M P im p l em entation f or veterinary p roducts w il l occur in a sim il ar

earl ier th an orig inal l y th oug h t. F urth erm ore, m ark eting auth oriz ation h ol ders f or anim al h eal th p roducts w il l b e exp ected to reg ister and w ork w ith th e O M S and R M S w h en th ey g o l ive — p ossib l y as earl y as l ate 2 0 1 7 — in order to com p l y w ith p h arm acovig il ance req uirem ents.

1 1 Identification of medicinal products (IDMP) An op p ortunity to unl ock th e val ue of p roduct data

R e a l i z i n g t h e f u l l p o t e n t i a l o f I D M P c o m p l i a n c eM ost of th e g ap anal yses conducted to date h ave f ocused on data, f orm ats and source system s. H ow ever, our deep er, p ortf ol io- l evel anal yses of I D M P attrib utes h ave reveal ed b roader actions req uired to h el p unl ock true val ue f rom I D M P investm ent.

Th ese actions incl ude:

► Assess h ow to l everag e O M S and R M S integ ration w ith I D M P into

investm ents in O M S and R M S can b e f urth er util iz ed as you m ove ah ead w ith your I D M P j ourney

► R evisit your I D M P investm ent b usiness case to articul ate cl earl y th e b roader b usiness val ue b eyond com p l iance, encom p assing

external p artners, incl uding contract m anuf acturers, distrib utors and al l iance p artners

► Al ig n your I D M P p rog ram w ith p aral l el rel ated initiatives such as serial iz ation, p h arm acovig il ance up dates and F D A S tructured P roduct L ab el ing ( S P L )

► D esig n a cost- ef f ective, steady- state op erating m odel f or your I D M P data set w ith in a b roader b usiness context, i. e. , enh ancing

cycl e m anag em ent activities; th is m odel m ust b e sustainab l e and cost- ef f ective, yet al so ab l e to adap t to th e ch ang es b roug h t ab out b y acq uisitions, divestm ents and p artnersh ip s

► Targ et investm ent in I D M P aw areness th roug h out th e org aniz ation, f rom R & D th roug h to reg ul atory, com m ercial and m anuf acturing

K e y q u e s t i o n s

1 usiness impact assessmentH ave you conducted a h ol istic b usiness im p act assessm ent to sup p l em ent th e I D M P g ap anal ysis, incl uding external p artners?

2 Process implicationsH ow w el l do you understand th e p rocess im p l ications of I D M P across th e enterp rise, in R & D and th roug h out th e p roduct l if e cycl e, e. g . , m anag em ent of variations?

3 peratin model sustaina ilit

a sustainab l e I D M P op erating m odel , e. g . , inf orm ation g overnance and structured auth oring ?

4 usiness led data o ernanceH ave you considered th e need f or a b usiness- l ed data g overnance f ram ew ork to sustain th e integ rity of underl ying I D M P inf orm ation?

5 Implementation pra maticsH ave you considered th e m ag nitude of ef f ort associated w ith data readiness, incl uding identif ying sources, col l ating inf orm ation and instantiating rep ositories?


or more information contactris Moore

EY EMEIA Advisory Services Leader, Life Sciences

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Mic elle uddi an EY EMEIA Advisory Centre, Life Sciences

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ris McDonnell Ernst & Young LLP, Advisory Services, Life Sciences

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armila a aratnam EY EMEIA Advisory Centre, Life Sciences

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1 3 Identification of medicinal products (IDMP) An op p ortunity to unl ock th e val ue of p roduct data

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H o w EY’ s G l o b a l L i f e S c i e n c e s S e c t o r c a n h e l p y o u r b u s i n e s sAs p op ul ations ag e and ch ronic diseases b ecom e com m onp l ace, h eal th care w il l tak e an ever l arg er sh are of G D P . S cientif ic p rog ress, aug m ented intel l ig ence and a m ore em p ow ered p atient are driving ch ang es in th e del ivery of h eal th care to a p ersonal iz ed exp erience th at dem ands h eal th outcom es as th e core m etric. Th is is causing a p ow er sh if t am ong traditional stak eh ol der g roup s, w ith new entrants ( of ten not driven b y p rof it) disrup ting incum b ents. I nnovation, p roductivity and access to p atients rem ain th e industry’ s b ig g est ch al l eng es. Th ese trends ch al l eng e th e cap ital strateg y of every l ink in th e l if e sciences val ue ch ain, f rom R & D and p roduct sup p l y to p roduct l aunch and p atient- centric op erating m odel s.

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